Improving Provider Counseling Interventions in HIV Practice

October 17, 2018 updated by: Johns Hopkins University
Hypothesis: HIV clinicians trained to deliver brief counseling messages and receiving cues from a brief computer survey on risk behaviors of their patients can counsel have an impact on patient's risk behaviors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized controlled study. The purpose of this study is to assess the impact of the cue sheet as an aid to targeted provider behavioral counseling. All enrolled participants are HIV+ adults seen for regular medical care at a site affiliated with the Johns Hopkins AIDS Service. After consenting, participants will take an audio-assisted computer interviews to collect patient risk assessment data. For participants randomized to the intervention arm, the printed output on risk behaviors is then given to the provider along with cues for staged-based counseling for use during the same visit. Participants in the control arm take the same computerized risk assessment but there are no printed cue sheets. Risk behaviors of all participants are assessed at entry, at 6 months, and at 12 months. The main outcome measure is change in HIV transmission behaviors at 12 months for those in the intervention arm compared to the control arm.

Study Type

Interventional

Enrollment (Actual)

470

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HIV seropositive
  • English speaking

Exclusion Criteria:

  • Cannot give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Provider receives cue sheet to assist with counseling.
Behavioral: Stage based counseling
No Intervention: 2
Provider does not receive cue sheet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disclosure of HIV status to sex partners; unprotected sexual encounters.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

University of California, San Francisco

Investigators

  • Principal Investigator: Emily Erbelding, M.D., Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2003

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

October 1, 2007

First Submitted That Met QC Criteria

October 1, 2007

First Posted (Estimate)

October 3, 2007

Study Record Updates

Last Update Posted (Actual)

October 18, 2018

Last Update Submitted That Met QC Criteria

October 17, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H97HA01144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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